A Study To Evaluate The Effect Of GW876008 On The Pharmacokinetics Of Oral Contraceptive Pills

NCT00508911 | Terminated Phase 1

• 1 other identifier: CRH103002
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted in healthy female volunteers to investigate the effect of GW876008 on the pharmacokinetics of oral contraceptive pills.

Conditions

Social Phobia

Keywords

open-label,; oral contraceptive,; Combine Oral Contraceptives,; single-sequence,; volunteers; GW876008,; repeat-dose,; female,; pharmacokinetics,

Outcome Measures

Primary Outcomes (1)

• Blood level of oral contraceptive pills

  measured over 24hrs on Day 28 of Period 1 and 2

Secondary Outcomes (6)

• 1)PK parameters of oral contraceptives

  Day 28

• 2)PK parameters of GW876008

  Days 28 and 35 (Period2)

• 3)Blood level of sex hormones 4) Frequency of breakthrough bleeding 5) adverse event,12-lead ECG and vital signs and laboratory tests

  (throughout study)

• Ethinylestradiol and levonorgestrel blood levels to determine pharmacokinetic parameter

  Session 1: Day 28 at pre-dose (-30 mins), 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose. Session 2: Day 28 at pre-dose (-30 mins), 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose. Days 30-35

• Serum concentrations of LH, FSH.

  Pre-dose on Days 8, 12 and 19

Study Arms (1)

Healthy female subjects

EXPERIMENTAL

Each subject will be administered a monophasic combined oral contraceptive (COC) containing ethinylestradiol 30 micrograms and levonorgestrel 150 micrograms for two complete cycles (Day 8 to Day 28) in Session 1. The subjects will be administered COC on Day 8 to Day 28 and GW876008 125 milligrams on Days 1 to 35 in Session 2.

Drug: GW876008; Drug: COC

Interventions

GW876008 DRUG

GW876008 tablets will be available as white to off-white coated tablets. Each subject will receive a single oral dose of GW876008, daily for up to 35 days in Session 2. GW876008 will be administered in the morning with a light breakfast.

Also known as: GW876008 Oral Contraceptive

Healthy female subjects

COC DRUG

COC containing ethinylestradiol 30 microgram and levonorgestrel 150 microgram will be administered in the morning with a light breakfast.

Healthy female subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females of childbearing potential, who:
• have been taking for at least 3 months a monophasic combined oral contraceptives (COC) (21 repeat-days administration + 7-days washout) containing ethinyloestradiol 30µg and levonorgestrel 150 µg;
• are willing to continue a monophasic COC containing ethinyloestradiol 30µg and levonorgestrel 150 µg from at least the commencement of their last normal period prior to the first dose of study medication;
• are willing to continue a monophasic COC containing ethinyloestradiol 30µg and levonorgestrel 150 µg until 14 days after last treatment or until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after last treatment, whichever is the longest.
• Women should have a regular menstrual cycle of approximately 4 weeks duration in the preceding 3 months.
• Females of childbearing potential will be required to use other adequate contraception, in addition to the COC
• Aged 18-45 years inclusive.
• Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their medical and psychiatric history (including family), physical examination, laboratory studies, and other tests.
• Body weight ≥ 45 kg for women and BMI within the range 18.5-29.9 kg/m2 inclusive;
• Demonstrates no evidence of active disease, physical or significant mental impairment.
• Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
• Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
• Agrees to abstain from ingesting caffeine or xanthine-containing products for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.
• Agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.
• Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG and a 24 hour Holter ECG).

You may not qualify if:

• As a result of any of the medical interview, physical examination or screening investigations the physician responsible considers the subject unfit for the study.
• Any clinical condition in which the COC is contra-indicated
• Female subjects who are currently or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving study drug).
• The subject has a positive pre-study urine drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• A positive pre-study HIV 1/2, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• Any history of suicidal attempts or behaviour.
• History of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging \> 14 drinks/week for women \[1 drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits\] within 6 months of screening.
• Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
• Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
• Pepsinogen I, ACTH, cortisol, TSH, Total T4, Free T4 at screening/baseline outside \> 5% of normal range.
• LFTs elevated above the reference range at pre-study screening that remain elevated with a repeat LFT
• Any other clinically significant laboratory abnormality.
• The subject has a screening ECG with values outside the ranges defined in the protocol
• History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
• The subject has participated in a clinical trial and has received a drug or a new chemical entity within 90 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Harrow, Middlesex, HA13UJ, United Kingdom

Location

Related Links

• Results for study CRH103002 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Phobia, Social

Interventions

GW 876008

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: June 8, 2007
• Primary Completion: October 22, 2007
• Study Completion: October 22, 2007
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

GB (1)